Obesity Clinical Trial
Official title:
Clinical Investigation on the Safety of Avocado Pulp Lipids
Obesity and diabetes are a significant global burden and there is an immediate need for novel
treatments and management strategies. Our laboratory determined that avocado derived 17
carbon polyhydroxylated fatty alcohols (PFAs) are inhibitors of fatty acid oxidation (FAO)
that impart minimal toxicity in mice. FAO is altered in numerous disease states including
obesity and diabetes. In these chronic diseases, excessive FAO in muscle and liver
mitochondria cause metabolic overload and inefficiency which drives obesity-associated
glucose intolerance and insulin insensitivity. The increased FAO that occurs in obese and
diabetic individuals depletes several substrates and intermediates of the Krebs cycle, making
them less efficient at using oxidative phosphorylation for energy, which can ultimately lead
to glucose insensitivity and weight gain. For these reasons, inhibition of FAO is now an
established therapeutic approach for the treatment of type II diabetes as reducing FAO: i)
improves cellular metabolism to shift towards the more thermogenic oxidative phosphorylation
and glycolysis, and ii) reduces hyperglycemia via inhibiting liver gluconeogenesis while
improving glucose homeostasis.
In collaboration with an industry partner, Advanced Orthomolecular Research (AOR; Calgary,
AB), the investigators have developed a supplement containing a blend of 17-carbon PFAs found
inside a commercially available food grade avocado powder. The primary objective of this
clinical trial is to determine if the avocado derived supplement is safe for oral consumption
compared to a placebo-controlled group.
This is a single center, double-blind, placebo-controlled, randomized clinical trial. 30 healthy subjects are planned. After screening and recruitment, subjects will be randomly allocated to treatment groups (low dose avocado powder or high dose avocado powder) or placebo control group. Once recruitment, randomization, baseline measurements as well as treatment allocation is completed (on the first site visit), each subject will orally consume one scoop (30-35g of material) of the avocado supplement, blended in 12-16 ounces of a smoothie like diluent, once per day for 60 days. The placebo group will also consume one scoop (30-35g of material) containing only non-medicinal ingredients used in the test product. Primary and secondary endpoint evaluations will be taken at baseline (site visit 2), day 30 (site visit 3) and day 60 (site visit 4) at each of the 3 study site visits as well as via weekly telephone calls to participants. Total duration of subject participation will be 60 days. Total duration of the study is expected to be 61 days. ;
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